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Not yet recruitingNCT06996288Updated May 30, 2025

A Multicenter Randomized Controlled Clinical Trial of the Impact of Minimally Invasive Abdominal Surgery Esophageal Pressure Monitoring Guided Individualized PEEP on Postoperative Pulmonary Complications in Obese Patients

An interventional study of Transpulmonary pressure-guided individualized PEEP in PostoperativePulmonaryComplications, sponsored by Tianjin Medical University Cancer Institute and Hospital. Not yet recruiting. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-05-30.

Sponsored by Tianjin Medical University Cancer Institute and Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The aim of this study is to compare the effect of individualized PEEP based on transmural lung pressure and fixed PEEP on postoperative pulmonary complications during laparoscopic or robotic abdominal surgery in obese patients.

The main questions are:

  1. whether the intraoperative application of individualized PEEP in obese patients can reduce the incidence of postoperative pulmonary complications at 7d, 30d, and 90d postoperatively compared to fixed PEEP
  2. Whether the application of individualized PEEP in obese patients can optimize intraoperative respiratory mechanics, oxygenation index (PaO2/FiO2), PaCO2, and EtCO2 compared with fixed PEEP.

3 Whether the application of individualized PEEP in obese patients can reduce the incidence of non-respiratory complications, postoperative QoR-15 scores, unplanned reintubation, unplanned transfers, and unplanned extubation in the postoperative period compared with fixed PEEP. planned reintubation, unplanned transfers to ICU and ICU days, hospitalization days, 30-day and 90-day mortality.

Participants will:

Patients with BMI >= 30 kg/m² undergoing laparoscopic or robotic abdominal surgery received PEEP during surgery (divided into individualized PEEP and fixed PEEP), and were followed up for 90 days to observe the incidence of pulmonary complications and related study outcomes.

02

Conditions studied

  • PostoperativePulmonaryComplications
03

In context

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ≥18 years of age; ASA class I-III. Patients undergoing bariatric laparoscopic or robotic abdominal surgery; BMI ≥30 kg/m²; Planned operative time ≥120 minutes.

Exclusion criteria

Exclusion Criteria:

  • Presence of other serious cardiorespiratory diseases, such as severe chronic obstructive pulmonary disease (COPD, GOLD Class III-IV); history of severe or uncontrolled bronchial asthma, history of pulmonary resection; Presence of unstable cardiovascular disease, NYHA classification 3-4, such as severe arrhythmias or heart failure; Presence of neuromuscular disease affecting respiratory function, such as severe spinal cord injury; intracranial injury history of esophageal-related surgery, contraindications to esophageal catheter insertion, including severe coagulopathy (platelets \< 5000/μL or INR > 4) severe chronic liver disease (Child-Pugh score ≥ 12) Patients who cannot be extubated in time after surgery and need to return to the ICU with an endotracheal tube or are scheduled to be reintubated after surgery.

(7) general anesthesia duration less than 120 minutes

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Transpulmonary pressure-guided individualized PEEP group

    Preoperative assessment was performed based on basic information such as patient's age, height, weight, BMI classification, pulmonary function and blood gases. Intraoperatively, a ventilation strategy based on esophageal pressure (Pes) to monitor the transpulmonary pressure guidance was adopted, using a small tidal volume (6-8 ml/kg of ideal body weight), maintaining the transpulmonary pressure in the safe range of 5-15 cmH2O with PEEP at the level of Pes+1 cm H2O.

    Device: Transpulmonary pressure-guided individualized PEEP

  • No intervention
    The fixed PEEP

    The fixed PEEP group was the intraoperative ventilation strategy based on lung protection, using a small tidal volume (6-8 ml/kg of ideal body weight) and setting the PEEP level at 8 cmH2O.

Interventions

  • DeviceTranspulmonary pressure-guided individualized PEEP

    Transpulmonary pressure-guided individualized PEEP group was an intraoperative ventilation strategy based on esophageal pressure (Pes) monitoring of transpulmonary pressure-guided ventilation, using a small tidal volume (6-8 ml/kg of ideal body weight), maintaining the transpulmonary pressure in the safe range of 5-15 cmH2O PEEP for Pes+1 cm H2O level.

06

What researchers measure

Primary outcomes

  1. PostoperativePulmonaryComplications

    The primary outcome was acomposite of pulmonary complications within the first 7 postoperative days, including respiratory failure, acute respiratory distress syndrome, bronchospasm, new pulmonaryinfiltrates, pulmonary infection, aspiration pneumonitis, pleural effusion, atelectasis, cardiopulmonary edema, and pneumothorax.

    Time frame: From enrollment to seven days postoperatively

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Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06996288
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Responsible party
Sponsor
First posted
May 30, 2025
Start date
May 20, 2025 (estimated)
Primary completion
May 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
May 30, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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